On February 11th, the National Medical Products Administration (NMPA) announced that Merck & Co. (MSD) has received approval for its Class 5.1 new drug application for injection of ceftarosei-tazobactam sodium (Zerbaxa). Zerbaxa is a combination antibacterial drug containing the cephalosporin antibiotic cefuroxime and the β-lactamase inhibitor tazobactam.

Screenshot source: NMPA official website

Zerbaxa is an antibiotic combination drug originally developed by Cubist Pharmaceuticals. In 2014, Merck & Co. acquired Cubist for approximately $9.5 billion in cash, adding Zerbaxa to its portfolio. That same year, the product received FDA approval for the treatment of complicated urinary tract infections caused by certain Gram-negative bacteria and, in combination with metronidazole, for the treatment of complicated intra-abdominal infections. In June 2019, the FDA further expanded Zerbaxa's indications to include the treatment of hospital-acquired pneumonia/ventilator-associated bacterial pneumonia.

Screenshot source: Moentropy Pharmaceutical Database (Global Drug R&D Database)

Merck has previously completed a Phase 3 clinical study in China evaluating the efficacy and safety of this product in the treatment of complicated intra-abdominal infections. As a veteran in the antibiotic field, Merck has been deeply involved in this area for many years and has successfully launched over 20 antibiotic products, including many combination drugs, demonstrating its extensive experience and strong R&D capabilities in anti-infective treatment.

Screenshot source: Moentropy Global Drug R&D Database

In August 2022, the International Journal of Infectious Diseases (Int J Infect Dis) published results from a Phase 3 clinical study comparing the efficacy and safety of Zerbaxa combined with metronidazole and meropenem in the treatment of complicated intra-abdominal infections (cIAI) in Chinese patients. The core evaluation outcome was the clinical response rate of the test of cure (TOC). The publication of these study results further solidifies Merck's leading position in the treatment of complicated infections and offers potential therapeutic hope to more patients. We look forward to Merck's swift approval of this antibacterial combination therapy so that more patients can benefit.

Reference sources:
[1] NMPA official website
[2] Moentropy Pharmaceuticals (Original Drug Rongyun) Database